This invention relates to the field of sterile packaging of components to be used in certain medical operative procedures. More specifically, the invention relates to the packaging, in a single outer package, of various components used in such procedures where, because of the chemical nature of certain portions of some of the components, particular sterilization methods must be used with some of the components, while other different sterilization methods must be used with the others.
While the concept here-involved can be applied to the packaging of any medical procedure package requiring the inclusion of any medicament-containing vial which is conventionally sealed with a rubber closure plug or diaphragm, the packages provided by the present invention have particular use in X-ray radiographic procedures, such as myelographic procedures, in which a radiopaque contrast agent is injected into the spinal arachnoid space so as to provide X-ray visualization of the spinal chord. In such procedures, the skin area on the patient's spine where the injection is to be made is sterilized using appropriate sponge scrubbers and anti-bacterial agents. Then using a hypodermic syringe and a vial of local anesthetic, the area around the injection site is anesthetized. A spinal puncture needle is then inserted into the arachnoid space, and, if desired, samples of cerebro spinal fluid (CSF) are withdrawn by attachment of a cannula fitted with a male tapered joint on one end for attachment of the cannula to the puncture needle and a female tapered joint on the other end for attachment of the cannula to a hypodermic syringe, the samples being collected in small graduated sample tubes. The radiopaque solution is then withdrawn from a vial containing the same, conventionally sealed with a rubber plug, by puncturing the plug with a separate hypodermic needle and aspirating the solution into a syringe. The syringe is then disconnected from the aspirating needle, attached either directly to the puncture needle in the patient's spine or to the cannula attached to the needle, and the radiopaque medium is then injected into the arachnoid space. When the examination is complete, the puncture needle is withdrawn, leaving the radiopaque medium in place to be metabolized by the body, or, alternatively, the medium is removed by aspiration and then the puncture needle is withdrawn.
It will be clear from the above description that each of the various essential medical procedure components used in the myelographic procedure, including sponge scrubbers, local anesthetic syringe and vial, puncture needles with associated needle sheaths and closure caps, cannulas and associated closure caps, sample tubes, contrast agent vial and injection syringe, as well as miscellaneous items such as drapes to cover the patient and gauze pads for blotting fluids around the injection site during the procedure, must all be pre-sterilized before or during packaging and, most importantly, must be maintained in a sterile condition until used. The conventional approach to the problem of ensuring sterility in each of the components, some of which are typically made of plastic materials, has been to provide all the components, except the vial of contrast agent, in one package unit, such as a plastic tray typically made of polystyrene foam or thermoformed polystyrene, the vial of contrast agent being supplied in a separate package. This separation of the vial of contrast agent from the remainder of the package contents is necessary, because the components stored and shipped in the plastic trays cannot be heat sterilized due to the instability of the plastics to heat. Thus the trays and their associated essential medical procedure components can only be sterilized by ethylene oxide gas. On the other hand, the vial of contrast agent, which, as stated, is conventionally sealed with a pierceable rubber plug, cannot be sterilized by ethylene oxide because of the known destructive effect the latter has on rubber. Thus the contrast agent vial can only be heat sterilized. The present invention provides a unique means for maintaining complete sterility of all the components used in the procedure while combining all the components, including the contrast agent vial, into a single package unit.